"... Beginning June 1, 2009, FDA intends to no longer accept drug establishment registration and drug listing information in paper format unless a waiver is granted."
Draft Guidance for Industry and Reviewers on Structured Product Labeling Standard for Content of Labeling Technical Questions and Answers
IMPLEMENTATION NOTE [02-Nov-2009]: In the very near future, all valid new listing SPL documents associated with approved drug products should be posted for you to access via this link within 24 - 48 hours on business days. If you need the document posted right away for a submission then you can let us know via e-mail to//SPL@fda.hhs.gov//. In that e-mail, you should send the document ID associated with the submission and we should be able to have it posted within a few hours after it is processed by the eList system. FDAshould have all of the valid listing documents submitted prior to last week in the new repository within three weeks.
To comment on a Draft Guidance electronically, use
[201008021527 on front page is the latest release of] Structured Product Labeling Validation Procedures for Drug Establishment Registration and Drug Listing v2.0 PDF
Variations from earlier version are here.
Previous version [[201005011423] of Structured Product Labeling Validation Procedures for Drug Establishment Registration and Drug Listing v2.0 PDF
Variations from earlier version are here.
New rules (compared with earlier version) are here in handy spreadsheet format: [!!Thanks pdesai!!]
[200908241430 on front page is the previous release of] Structured Product Labeling Validation Procedures for Drug Establishment Registration and Drug Listing v2.0 PDF Variations from earlier version are here.
Instructions for using Electronic Drug Establishment Registration and Drug Listing XForms v2.0 PDF
SPL Standard for Content of Labeling Technical Questions and Answers HTML
Electronic Labeling Information Processing System (ELIPS) Validation and Conformance Rules PDF
Important FDA Documents for SPL
FDA Contacts
Points of contact web page: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/DrugRegistrationandListing/ucm254946.htm.Acts and Regulations
Guidance Documents
- Guidance for Industry: Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing
"... Beginning June 1, 2009, FDA intends to no longer accept drug establishment registration and drug listing information in paper format unless a waiver is granted."IMPLEMENTATION NOTE [02-Nov-2009]: In the very near future, all valid new listing SPL documents associated with approved drug products should be posted for you to access via this link within 24 - 48 hours on business days. If you need the document posted right away for a submission then you can let us know via e-mail to //SPL@fda.hhs.gov//. In that e-mail, you should send the document ID associated with the submission and we should be able to have it posted within a few hours after it is processed by the eList system. FDA should have all of the valid listing documents submitted prior to last week in the new repository within three weeks.
To comment on a Draft Guidance electronically, use
//Regulation.gov//
Implementation Guides (also known as "IG")
Structured Product Labeling Implementation Guide for FDA Drug and Biological Products v1.1 (updated January 16, 2007)
Structured Product Labeling Implementation Guide for FDA Drug Establishment Registration and Drug Listing v2.0
FDA SPL Starter Pack
[updated information 19-July-2010]The FDA Data Standards Council SPL web page now includes a "SPL Starter Package."
FDA SPL Supporting Documents
[24-Aug-2010: New Revision of Validation Rules]http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
Variations (Validation Rules only) from earlier version are
Variations from earlier version are here.
Variations from earlier version are here.
New rules (compared with earlier version) are here in handy spreadsheet format: [!!Thanks pdesai!!]
Data Standards Manual
Data Standards Manual
Controlled vocabulary links:
SPL Schema and Stylesheet
Docket Notifications for SPL Submission